Valeant appoints Parexel to aid retigabine applications

Valeant Pharmaceuticals has announced the appointment of Parexel International to help the company develop, coordinate and organise its applications to major regulatory bodies for the approval of retigabine.

The compound is currently being investigated at phase III as a treatment for partial-onset seizures in epilepsy patients, while the company has appointed Parexel to aid the preparation of applications for approval in both the European Union and the US.

Retigabine is an investigational neuronal potassium-channel opener being tested by the Restore phase III clinical trial for efficacy and safety as an adjunctive therapy for refractory epilepsy patients already being administered with one to three antiepileptic treatments.

Wesley P Wheeler, president of research and development in North America at the company, said: “Parexel’s regulatory expertise is anticipated to play a critical role in our development of retigabine.

“Valeant is committed to developing innovative drugs for neurological disorders, with a special focus on epilepsy.”

He added that Parexel’s past experience with filing for marketing approval with the European Medicines Agency and US Food and Drug Administration would prove useful as the company seeks endorsement of the compound.

Last month, Valeant announced the publication of positive phase II clinical trial results for retigabine as a treatment for partial-onset seizures in patients with refractory epilepsy.